Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

In-stent Coronary Artery Restenosis Clinical Trial

— PEPPER  

Official title:

Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961181
• Other study ID #: C0902
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: May 2, 2013
• Start date: August 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2013
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and InformationDenmark: Danish Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.

Description:

All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES).

Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient >/= 18 years

2. Written patient informed consent available

3. Patients with stable, unstable or documented silent angina pectoris

4. Patient eligible for percutaneous coronary intervention

5. Patient acceptable candidate for coronary artery bypass surgery

6. Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)

7. Target reference vessel diameter (visual estimation): 2 - 4 mm

8. Target lesion length (visual estimation): 8 - 28 mm

9. Target lesion stenosis (visual estimation): >/= 50% - < 100%

Exclusion Criteria:

1. Left ventricular ejection fraction of < 30%

2. Visible thrombus in the target vessel visualized by angiography

3. Myocardial infarction (STEMI/NSTEMI) within 72 hours of the intended treatment. Determination of CKMB and/or troponin T or I is required.

Notes:

Laboratory assessments to be done within 24 hours prior to intervention. Patients with CKMB and/or troponin T or I > 2 fold the upper limit of normal must not be included in the trial.

4. Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation

5. Lesion length longer than length of available treatment balloon

6. Impaired renal function (serum creatinine > 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention)

7. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment

8. Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)

9. Target lesion located in vessel bifurcation

10. Previous and/or planned brachytherapy of target vessel

11. Target lesion located in left main coronary artery

12. Stroke or TIA < 6 months prior to procedure

13. Patient with signs of a cardiogenic shock

14. Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus)

15. Surgeries of any kind within 30 days prior to screening

16. Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated

17. Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel

18. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential)

19. Patient with a life expectancy of less than one year

20. Patient currently enrolled in other investigational device or drug trial

21. Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy

22. Patient not able or willing to adhere to follow-up visits including follow-up angiography

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Restenosis
• In-stent Coronary Artery Restenosis

Intervention

Device:
• Paclitaxel Releasing Balloon
Percutaneous coronary intervention with paclitaxel releasing balloon

Locations

Country	Name	City	State
Germany	Prof. Dr. Christoph Hehrlein	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hehrlein C, Dietz U, Kubica J, Jørgensen E, Hoffmann E, Naber C, Lesiak M, Schneider H, Wiemer M, Tölg R, Richardt G. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent Late Lumen Loss	In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.; Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	6 months	No
Secondary	In-segment Late Lumen Loss	In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.; Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	6 months	No
Secondary	Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)	All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.; Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR	6 months	Yes
Secondary	Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)	All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.	12 months	Yes
Secondary	In-stent Diameter Stenosis (%DS)	In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.; Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	6 months	No
Secondary	In-segment Diameter Stenosis (%DS)	In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.; Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	6 months	No
Secondary	Binary In-stent Restenosis	In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.; Binary restenosis was defined as a = 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).; Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	6 months	No
Secondary	Binary In-segment Restenosis	In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.; Binary restenosis was defined as a = 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).; Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	6 months	No
Secondary	Technical Success	Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).; Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	directly after intervention (after finalized treatment)	No
Secondary	Device Success	Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA).; Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).	directly after intervention (after finalized treatment)	No